| Primary Device ID | 05707480041879 |
| NIH Device Record Key | c35c1ad4-e0b7-4b30-9817-30a9077c3cf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepmateOral / Nasal wo. Filter |
| Version Model Number | 814310-000/50 |
| Catalog Number | 814310-000/50 |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480041879 [Primary] |
| GS1 | 05707480133970 [Unit of Use] |
| BZQ | Monitor, breathing frequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-16 |
| Device Publish Date | 2016-09-21 |
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